(March 13, 3:28 p.m.) Despite repeated “objectionable findings” over a six year span, the U.S. Food and Drug Administration took virtually no meaningful enforcement actions resulting from inspections at packaged fresh spinach facilities.

What’s more, the FDA failed to look for sources of possible E. coli contamination in spinach fields and instead focused inspections solely on facilities.

Those are two central criticisms of the agency in a titled “FDA and Fresh Spinach Safety” issued by the majority staff of the House Committee on Oversight and Government Reform.

The March 12 report also said that the FDA allowed repeat violations to continue without corrective action.

The FDA defended its interactions with industry in an email response to The Packer.

“FDA provides inspectional observations to a firm during and at the conclusion of the inspection to allow the firm the opportunity to correct the problems identified,” said Sebastian Cianci, public affairs spokesman for the Food and Drug Administration.

Problems that are pointed out during an FDA inspection, he said, are typically corrected during or shortly following the inspection. If a problem needs an enforcement action, FDA won’t hesitate to ask for a recall or open criminal investigations and seek prosecution to punish violations, he said.

Regarding the report’s criticism that the FDA paid little notice to conditions in the field that could have had an impact on the safety of spinach, Cianci said FDA has traditionally focused on inspecting fresh produce processing establishments rather than farms.

“While no violation of standards is acceptable in the food chain, our efforts are focused on the areas that present the greatest risk of causing contamination to the food supply. FDA is not currently in a position to rank produce farms by risk,” Cianci said. “At this time, FDA is not able to inspect all the farms nor do we have enough inspectors to get to all farms in a reasonable time frame.”

He did note that the agency’s Food Protection Plan is looking at revising Good Agricultural Practices and the FDA has called on Congress to expand FDA’s legislative authority.

“One of those proposals is for explicit authority to require preventative controls for high risk foods that have been repeatedly associated with serious illness, and certain types of fresh produce would fall under that umbrella,” Cianci said.

The report’s criticisms of the agency were nothing new, said Scott Horsfall, chief executive officer of the California Leafy Green Products Handler Marketing Agreement, Sacramento, Calif.

“We all know that FDA has limited resources and I think they do what they can,” he said, declining to comment on specific criticisms of the agency.

However, Horsfall said the report’s criticism about FDA’s lack of field inspections was answered — in California and Arizona, at least — by the industry with the leafy greens marketing agreement.

He noted the inspection data the report examined were collected before the advent of the marketing agreement.

“At least in California, 99% of the industry is subject to mandatory government inspections on an ongoing basis,” he said.

“That’s why we focused on the field, because it was an area that wasn’t getting any attention,” he said.

While Horsfall declined to say if FDA needs more statutory authority, he said the agreement was serving a needed role.

“We believe mandatory government inspections are a good thing and part of any of verification process,” he said. “If corrective actions are necessary, they ought to be completed,” he said.


A specific criticism in the report was that FDA inspection records show that in the years prior to the outbreak, the agency conducted multiple inspections of several packaged fresh spinach facilities operated by San Juan Bautista, Calif.-based Natural Selection Food LLC “and repeatedly found problematic conditions at a number of these facilities.”

The report said inspection records show that the FDA didn’t require the firm to correct these conditions at any of its facilities, “even after laboratory tests indicated the presence of microbial contamination at the exact site later implicated in the 2006.”

Samantha Cabaluna, spokeswoman for Natural Selection Foods, LLC, San Juan Bautista, Calif., said the company agreed with the theme of the report that there is a need for strong federal oversight of food safety and a better-funded FDA.

“We are, however, concerned with several factual inaccuracies and misleading statements regarding our cooperation and safety processes,” she said. For example, she said the report refers to a July 2001 inspection of the “Natural Selection Foods facility in San Juan Bautista implicated in the 2006 spinach outbreak.” She noted Natural Selection Foods was not processing in the facility where the product linked to the outbreak was packed.

“Natural Selection Foods has thoroughly cooperated with both the FDA and CDHS and has provided inspectors with unlimited access to our two facilities in San Juan Bautista, California, and Yuma, Arizona,” she said in a prepared statement.

The company notes all observations from FDA inspectors during their audits, Cabaluna said. “All corrective actions are immediately addressed.” She said Natural Selection has demonstrated its commitment to product quality and food safety by putting in place what she called the “most comprehensive and aggressive” testing program to match the company’s rigorous agricultural and production standards.

Despite recent concerns, Cianci said the FDA believes that the U.S. food supply continues to be one of the safest in the world, “and this includes fresh produce."

The FDA has responded to the 2006 food borne illness outbreak in spinach with the Food Protection Plan rolled out last year.

That plan targets the greatest areas of risk for foods and applies preventive controls and inspections to those areas.

“Consistent adherence to Good Manufacturing Practice requirements in the processing facilities and Good Agricultural Practices on the farms and in the fields will help to minimize the risk of further outbreaks. We anticipate that the full implementation of the Food Protection Plan, will give FDA new authorities to further ensure that prevention of accidental and intentional contamination is drastically reduced before foods reach the consumer."

Regarding the charge that FDA has too limited a focus, Cianci said that is not the case.

FDA created the Leafy Greens Initiative in August 2006 as a response to the outbreaks that had occurred before the E. coli in spinach outbreak. The initiative is intended to reduce public health risks by focusing on the product, agents and areas of greatest concern.